Trial Information

In Vivo Real-time Detection of Circulating Melanoma Cells

Study Population: Approximately 80 subjects will be consented in order to achieve an
enrollment goal of 75 subjects at this institution in three cohorts as follows:

1. Cohort #1 will consist of fifteen healthy control subjects, ten of whom will be
Caucasian and five of whom will be African-American. Subjects in cohort #1 will be used
to address the calibration goal of Specific Aim #1.

2. Cohort #2 will consist of 30 subjects who have advanced-stage melanoma will be
recruited from the Medical Oncology clinic at UAMS, where advanced stages are defined
as Stages III or IV. Subjects in cohort #2 will be used to address the validation goal
of Specific Aim #2. Approximately half of the 30 advanced-stage subjects will be Stage
III and the other half will be Stage IV.

3. Cohort #3 will consist of 30 subjects with early-stage melanoma will be recruited from
the Surgical Oncology clinic at UAMS, where early stages are defined as Stages I or II.

Subjects in cohort #3 will be used to address the detection goal of Specific Aim #3.
Approximately 10 of the 30 early-stage subjects will be Stage I and approximately 20 will be
Stage II.